Associate Director, Technical PDS&T
We are seeking an exceptional leader to head our Product Development, Science and Technology team in Mayo. This individual will oversee a global team of scientists working on late-phase projects, leveraging their expertise in analytical methods and bioassays. The Associate Director will be responsible for goal setting, performance management, people development, and project leadership.
Key Responsibilities:
1. Lead the PDS&T team, guiding scientists in goal setting, performance management, people development, promotion recommendations, and salary management.
2. Develop and implement cross-functional strategies for late-stage development and validation of analytical methods.
3. Define CMC/analytical strategies for global product development programs.
4. Troubleshoot complex analytical methods, including cell-based potent assays and biological assays.
5. Liaise with early development functions, interacting with Operations, Regulatory, and technical plant functions.
6. Lead method transfers to global regulatory agency laboratories.
7. Oversee content of quality and global regulatory submission documents.
8. Perform financial planning and execute budget responsibility.
Requirements:
1. Masters or PhD degree required.
2. Four+ years of leadership experience.
3. Strong background and knowledge in Analytical Methods and Bioassays.
4. R&D experience.
5. Minimum 8 years working in GMP environments.